Zenith® Fenestrated+ Endovascular Graft Clinical Study
Cook Research Incorporated
Summary
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries. Up to 60 additional subjects may be enrolled in Continued Access phase of the study
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Include Criteria: 1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females 2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months 3. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter \> 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator Exclusion Criteria: 1. Age \< 18 years 2. Life expectancy \< 2 years 3. Pregnant, breast-feeding, or planning to become pregnant within 60 months 4. Inability or r…
Interventions
- DeviceZenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
Endovascular aneurysm repair
Locations (33)
- University of Alabama Birmingham HospitalBirmingham, Alabama
- UC San DiegoLa Jolla, California
- University of Southern CaliforniaLos Angeles, California
- Stanford Hospitals and ClinicsStanford, California
- Medstar Washington Hospital CenterWashington D.C., District of Columbia
- University of Florida Shands HospitalGainesville, Florida